Effect of different durations of compression therapy on quality of life and recurrence after thermal ablation for varicose veins: a protocol for a prospective, multicenter, randomized controlled trial

Background Compression therapy is routinely recommended after the thermal ablation of varicose veins (VVs), but the optimal duration of treatment remains controversial. International guidelines acknowledge the lack of evidence to support a specific duration of compression therapy (grade 2C). In current clinical practice, the selection of therapy options (1–3 months or even longer) rely mainly on the clinical judgment of physicians, with significant variability in patient compliance and quality of life. This trial aims to determine the effects of different compression durations (1, 3, and 6 months) on recurrence, quality of life, and complications at 12 months after surgery. Methods This will be a prospective, multicenter, randomized, parallel-group trial. This study will include 600 patients with great saphenous vein insufficiency (C2–C6) treated with endovenous radiofrequency or laser ablation at 7 high-volume centers. The participants will be randomly assigned to the following groups at a 1:1:1 ratio: the one-month (OM) group, which will wear class II compression stockings (23–32 mmHg) for 1 month after surgery; the three-month (TM) group, which will wear compression stockings for 3 months; and the six-month (SM) group, which will wear compression stockings for 6 months. All the groups will wear the same compression stockings and follow the same instructions for wearing the stockings. The primary outcome is the recurrence of VVs at 12 months; the secondary outcomes include the closure rate of the great saphenous vein, disease-specific quality of life assessed by the Aberdeen Varicose Vein Questionnaire (AVVQ), the Chronic Lower Limb Venous Insufficiency Questionnaire (CIVIQ) score, the Venous Clinical Severity Score (VCSS), the incidence of postoperative complications (pain, ecchymosis, paresthesia, deep vein thrombosis, etc.), and patient compliance. The follow-up times are 1, 3, 6, and 12 months after surgery. Discussion This trial fills a key gap in evidence concerning the optimal duration of compression therapy after endovenous thermal ablation and the effect of providing optimal compression therapy on recurrence. The results of this study will provide high-level evidence for a standardized duration of compression therapy and contribute to updated future clinical guidelines. Clinical trial registration chictr.org.cn , identifier ChiCTR2100049550.